Generic Riluzole on the Market

The FDA granted approval to three drug companies June 18, 2013, to market generic versions of the ALS drug riluzole

Generic versions of riluzole, the only FDA-approved drug for the treatment of ALS, are now approved for sale in the United States.

Article Highlights:

Riluzole (brand name Rilutek) — which was developed based on MDA-supported research on the neurotransmitter glutamate — is the only drug approved by the U.S. Food and Drug Administration to treat amyotrophic lateral sclerosis.

On June 18, 2013, the FDA approved marketing in the United States of generic versions of the drug to three pharmaceutical companies: Apotex Corp., Glenmark Generics and Sun Pharmaceuticals.

Generic drugs are equivalent to brand-name drugs but typically are less expensive.

Generic drugs are equivalent to brand-name drugs but typically are less expensive. This is because the manufacturers of generic drugs don't have to recover the costs associated with the initial development and testing of the drug.

Riluzole, which is believed to interfere with the nervous system chemical glutamate, is the only drug approved by the FDA to treat ALS and is associated with a modest increase in survival time. Its development was based in part on MDA-supported research on glutamate. Researchers believe that excessive signaling by glutamate, a central nervous system neurotransmitter, may play a role in neurodegenerative diseases such as ALS.

Sanofi received FDA approval to market riluzole under the brand name Rilutek in December 1995. The company's patent for the drug, which gave it exclusive marketing rights in the United States, expired June 18, 2013.

Rilutek currently is sold in the United States by Covis Pharmaceuticals, which acquired the rights to market the drug in April 2013.